Supplier management—also known as “vendor management”—is a term encompassing a broad array of regulatory requirements and industry activities necessary to develop, manage and control active pharmaceutical ingredients, foods, pharmaceutical and biological products, cosmetics, veterinary products and medical devices. US Food and Drug Administration (FDA) regulations and guidance documents help ensure that such products are consistently developed, produced, distributed and otherwise controlled according to quality standards whenever suppliers are involved. Most regulatory agencies and nongovernmental organizations (NGOs) around the world embrace similar regulations and guidelines as a core requirement of doing business in today’s global marketplace.
This course provides a basic understanding of current supplier management practices and their impact on product quality and patient safety. It covers a wide range of issues, including why regulations and guidance documents targeting supplier oversight are increasing in rigor; how companies ensure compliance; what are the basic roles and responsibilities of regulatory and quality professionals; and which are the most common regulatory issues stemming from poor supplier performance and weak supplier management. This course will help you understand the key risks associated with suppliers and how best to help your organization as a regulatory professional.